Navigation Links
Crucell's Rabies MAb Enters Phase I Trial in India

Dutch biotechnology company, Crucell N V’s Rabies monoclonal antibody (mAb) product has entered a phase I clinical study in India, four months after launching// a similar study in the US.

Crucell has developed a human monoclonal antibody product for the post-exposure prophylaxis of rabies, using Crucell’s MAbstract and Crucell’s PER.C6 technologies. This second phase I study is closely linked to the initial phase I study that is currently being performed in the US. Both studies are conducted under FDA authority, the Indian phase I study gained approval upon review by the Drug Controller-General of India (DCGI).

The clinical trial will be a randomized, double-blind, placebo controlled study in 44 healthy volunteers that will test the antibody product alone in a dose escalation as well as in combination with rabies vaccine. The study, funded by Crucell, will be conducted through a undisclosed clinical research organization in Mumbai, India. The main parameters under investigation will be safety, tolerability and rabies virus neutralizing activity.

“We are very pleased that would could initiate this second phase I trial, as it follows favorable interim safety and tolerability data from the initial US study. The clinical testing of the Rabies antibody cocktail in Asia is the next important step for the program, as the global burden of Rabies is mostly affecting this continent. In addition to clinical evaluation of the rabies mAb cocktail in India, we are currently exploring the conduct of clinical trials in other Asian countries, including China,” said Mr Jaap Goudsmit, Chief Scientific Officer at Crucell.

Dr Deborah Briggs, Director of the Alliance for Rabies Control opined that there is a tremendous need for additional sources of rabies immune globulins (RIG) throughout the world, especially in Asia where less than three percent of patients undergoing post-exposure prophylaxis actually receive passive immune produ cts. She said new mAb products similar to Crucell’s product will soon be available to help to solve the shortage problem and save human lives.

Source: BioSpectrumSRM

Related medicine news :

1. Transfer Of Rabies Virus Possible From Organ Donor To Recipient
2. Rabies Requires Immediate Treatment
3. Student Bitten By Bat And Diagnosed With Rabies In Critical Condition
4. WB Asks Centre To Continue Supply Of Anti-Rabies Vaccine
5. Community Awareness Is Imperative For Eradication Of Rabies
6. Digital ID Chips Implanted in Dogs to Prevent Rabies
7. International Collaboration Takes Aim at Rabies
8. Bharat Biotech Launches Anti-Rabies Vaccine
9. WHO on an Anti Rabies and Snake Bite Mission
10. More Indians Die of Rabies Annually
11. New Vaccine to Tackle Rabies in Dogs
Post Your Comments:

(Date:12/1/2015)... ... December 01, 2015 , ... World Patent Marketing , ... a container patent that allows for easier packing and organizing of items into one ... $90 billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing and ...
(Date:12/1/2015)... ... December 01, 2015 , ... Integrated Rental Services ... Jordan Industries International, LLC (“JII”). , With support from JII, Integrated Rental is ... to hospitals, surgery centers, clinics, research labs and medical facilities across the United ...
(Date:12/1/2015)... Fla. (PRWEB) , ... December 01, 2015 , ... ... number of leadless pacemakers in the U.S. and is the only hospital in ... from the largest clinical data presentation of transcatheter pacing patients were revealed recently ...
(Date:12/1/2015)... ... December 01, 2015 , ... Growth in medical payments per workers’ compensation ... utilization of hospital and nonhospital care, according to a recent study by the Workers ... 16th Edition , found medical payments per claim with more than seven days of ...
(Date:12/1/2015)... ... ... It’s official: Tattoo taboo is a thing of the past. One in five ... one in three aged 18 to 25 is inked). As tattoos transition to mainstream ... fact, RealSelf , the world’s largest community for learning and sharing information about ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... , Dec. 1, 2015 ... today announced that its Chief Executive Officer, ... the Oppenheimer Annual Healthcare Conference in New ... in the conference through a webcast on ... , --> ...
(Date:12/1/2015)... Pharma Tech Outlook recently conducted a comprehensive ... Management Solution Providers - 2015 .  After careful consideration ... CIOs, VCs, analysts, and the Pharma Tech Outlook editorial ... 10 clinical data management solution providers (check out the ... 36 respectively). --> ...
(Date:12/1/2015)... , 1 de diciembre de 2015 /PRNewswire/ ... para cuchillas de precisión, develó hoy un ... identidad de marca. El nuevo logo destaca ... y la ingeniería de productos con cuchillas ... ...
Breaking Medicine Technology: